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Court Documents Suggest Bayer Neglected to Add Vital Information to New Drug Applications

Amidst the onslaught of controversy surrounding fourth generation oral contraceptives, new findings lend weight to the long-suspected link between newer birth control pills and severe, life-threatening blood clots. According to the former head of the U.S. Food and Drug Administration (FDA), Bayer may have purposely deceived U.S. regulators by neglecting to inform them of increased reports of blood clots in those who use Yasmin.

According to federal court documents in Illinois, Bayer neglected to include an analysis “that demonstrated an increase in the U.S. reporting rate” for venous thromboembolism, or blood clots, in their 2004 safety review of Yasmin. Also acknowledged by the court document, was a distinct absence of the opinions of the company’s researchers who were in charge of safety and effectiveness data. According to the earlier draft opinion, “spontaneous reporting data does signal a difference in the VTE rates for Yasmin” when compared to older forms of oral birth control.

Taking place of the original opinions in the previous draft, was a selective interpretation of the data as Bayer saw fit. The former head of the FDA, David Kessler, revealed that “Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin.”

According to Kessler, Bayer also failed to report two independent circumstances in which patients using Yasmin developed blood clots prior to the drug’s approval by the agency. “Had I, or a medical review officer, known these facts prior to approval, further investigation would be warranted before a decision on Yasmin’s NDA could be made,” he said, referencing the company’s new drug application. He continued to suggest that Bayer may have purposefully neglected to add this information to the safety report because of the negative influence it would have had while attempting to get the drug approved by the FDA. “These facts would impact the agency’s risk-benefit equation about the drug and whether it could be approved,” Kessler said.

Kessler’s report, along with four similar expert opinions, was revealed to the public this week by the representatives of former Yasmin users. According to the reports, the experts received payments from the plaintiffs’ lawyers, who submitted the reports to the FDA. In a meeting scheduled for December 8, the FDA plans to discuss future safety regulations pertaining to the safety and effectiveness of Fourth generation contraceptives like Yasmin. Kessler’s report, along with the expert opinions of four others, may play a significant role in determining any future regulations on the products.

Pressing the issue even further are approximately 10,000 current lawsuits filed against Bayer, each of which involve alleged injuries caused by contraceptives. Litigation over the alleged Yasmin injuries include at least 50 deaths related to the pills between 2004 and 2008. The first trials are scheduled for next month in a federal court in Illinois and a subsequent state court in Philadelphia.

Do I Have a Yasmin Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Yasmin lawsuits. We are currently accepting new cases in all 50 states.

If you or a loved one has been injured by Yasmin, you may be entitled to financial compensation. For a free case review, please click the link below or call toll free 24 hrs/day 1-800-773-0849.

Categories: Product Liability
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